NCT04396990

The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study

A Randomized, Controlled, Masked (Reading Center) Prospective Study of the Effectiveness and Safety of the Ocular Therapeutix Dextenza 0.4 mg for the Treatment of Post-op. Inflammation and Pain in PRK

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vance Thompson Vision · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.

Detailed description

Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.

Conditions

• Refractive Surgery

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
DRUG	Topical Prednisolone	Standard of care topical drop treatment

Timeline

• Start date: 2020-06-08
• Primary completion: 2020-09-28
• Completion: 2020-09-28
• First posted: 2020-05-21
• Last updated: 2024-07-30
• Results posted: 2023-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study